[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.50]
[Page 244]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 25 ENVIRONMENTAL IMPACT CONSIDERATIONS--Table of Contents
Subpart E Public Participation and Notification of Environmental
Documents
Sec. 25.50 General information.
(a) To the extent actions are not protected from disclosure by
existing law applicable to the agency's operation, FDA will involve the
public in preparing and implementing its NEPA procedures and will
provide public notice of NEPA-related hearings, public meetings, and the
availability of environmental documents.
(b) Many FDA actions involving investigations, review, and approval
of applications, and premarket notifications for human drugs, animal
drugs, biologic products, and devices are protected from disclosure
under the Trade Secret Act, 18 U.S.C. 1905, and 301(j) of the act. These
actions are also protected from disclosure under FDA's regulations
including part 20, Sec. Sec. 312.130(a), 314.430(b), 514.11(b),
514.12(a), 601.50(a), 601.51(a), 807.95(b), 812.38(a), and 814.9(b) of
this chapter. Even the existence of applications for human drugs, animal
drugs, biologic products, and devices is protected from disclosure under
these regulations. Therefore, unless the existence of applications for
human drugs, animal drugs, biologic products, or premarket notification
for devices has been made publicly available, the release of the
environmental document before approval of human drugs, animal drugs,
biologic products, and devices is inconsistent with statutory
requirements imposed on FDA. Appropriate environmental documents,
comments, and responses will be included in the administrative record to
the extent allowed by applicable laws.
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